# Ceribell, Inc.

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 16 (2017–2026): 16 510(k) clearances
- Product codes: GXY (7), OMB (5), OMC (2), NCG (1), OLT (1)
- 510(k) review time since 2016: median 130 days, against 138 for FDA's reviews in the same codes and years (6 of 10 faster)
- Predicates its devices cite: 24 (14 its own); citations of its devices by later devices: 27 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wuhan Greentek Pty, Ltd.: 2 (https://510kreport.com/company/wuhan-greentek)
- Ait Austrian Institute of Technology GmbH: 2 (https://510kreport.com/company/ait-austrian-institute-of-technology)
- Oxford Medilog, Inc.: 1 (https://510kreport.com/company/oxford-medilog)
- Hydrodot, Inc.: 1 (https://510kreport.com/company/hydrodot)
- Prolira B.V.: 1 (https://510kreport.com/company/prolira)
- Persyst Development Corporation: 1 (https://510kreport.com/company/persyst-development)
- Holberg Eeg AS: 1 (https://510kreport.com/company/holberg-eeg)
- Bioserenity Sas: 1 (https://510kreport.com/company/bioserenity)

## Firms that cite its devices most
- Epitel, Inc.: 3 (https://510kreport.com/company/epitel)
- Forest Devices, Inc.: 2 (https://510kreport.com/company/forest-devices)
- Ait Austrian Institute of Technology GmbH: 2 (https://510kreport.com/company/ait-austrian-institute-of-technology)
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek): 2 (https://510kreport.com/company/natus-medical-dba-excel-tech-xltek)
- Nihon Kohden Corporation: 2 (https://510kreport.com/company/nihon-kohden)
- Neurosteer, Inc.: 2 (https://510kreport.com/company/neurosteer)

## Its most-cited devices
- K170363: Ceribell Pocket EEG Device (2017), cited by 7
- K171459: Ceribell Instant EEG Headband (2017), cited by 5
- K191301: Ceribell Pocket EEG Device (2019), cited by 5
- K232052: Ceribell Instant EEG Headband (2023), cited by 3
- K223086: Ceribell Instant EEG Headcap (2023), cited by 2
- K210805: Ceribell Instant EEG Headband (2021), cited by 2

## Recent decisions
- K261712: Ceribell EEG Analysis Software (Sep 16, 2026)
- K261101: Ceribell Monitor (Jun 30, 2026)
- K260998: Ceribell Neurology Review Software (Jun 24, 2026)
- K260363: Ceribell Brain Monitor Headband (Apr 3, 2026)
- K254033: Ceribell Instant EEG Headset (Feb 9, 2026)
- K251936: Ceribell Delirium Monitor System (Dec 8, 2025)
- K252070: Ceribell Infant Seizure Detection Software (Nov 21, 2025)
- K251381: Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (Oct 31, 2025)

Source page: https://510kreport.com/company/ceribell